A Portable Thoracic Impedance Device for Detecting Pulmonary Congestion in Heart Failure Patients (DISPLAID1)

This study investigates a portable thoracic bioimpedance tomography (TBIT) device designed to detect early lung congestion in heart failure patients. The main goal is to evaluate how well the device's measurements match those obtained from lung ultrasound and other imaging techniques. By detecting lung fluid build-up before symptoms worsen, this device could help manage heart failure more effectively outside of hospital settings, potentially improving patient care and reducing hospital admissions. Participants in the study are monitored using this device along with standard imaging methods, and data on heart failure symptoms are collected to understand the device's accuracy and usability.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Diagnostic test: Thoracic bioimpedance tomography

Detailed Description

The primary objective is to determine the correlation between TBIT measurements and B-line scores obtained via portable lung ultrasound, with secondary objectives including correlations with thoracic water content from high-resolution CT scans, heart failure symptoms, and NT-proBNP levels adjusted for renal function. Conducted as a prospective, cross-sectional diagnostic study, the research involves heart failure patients recruited during hospital admissions or outpatient visits at heart failure and nephrology clinics. Data collected include TBIT, ultrasound, and CT imaging results, clinical data on heart failure severity, and symptom questionnaires. The study will assess correlations using statistical models such as Spearman's correlation coefficient and mixed-effects models, aiming to validate TBIT as a non-invasive, cost-effective tool for early detection of pulmonary congestion, potentially improving outpatient management and reducing heart failure-related hospitalizations. Ethical considerations include informed consent, confidentiality measures, and ensuring participant safety, with the study procedures being observational and not altering patient treatment based on TBIT results.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: William Beaubien-Souligny, MD PhD; Phone Number: 12759 15148908000; Email: william.beaubien-souligny.med@ssss.gouv.qc.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2X 3H8
      • Recruiting
      • CHUM
      • Contact: William Beaubien-Souligny, MD PhD; Phone Number: 5143773733; Email: william.beaubien-souligny.med@ssss.gouv.qc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Persons with congestive heart failure

Description

Inclusion Criteria:

• Adults aged 18 years or older.
• Diagnosed with heart failure, defined by the following criterion: hospitalization or an emergency visit for decompensated heart failure (pulmonary edema) within the last 12 months.

Exclusion Criteria:

• Pregnant women at the time of eligibility evaluation.
• Presence of an implanted electronic device in the thorax, such as a pacemaker or defibrillator.
• Inability to provide informed consent.
• Admission to intensive care or the coronary care unit.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient with congestive heart failure; Patients with a diagnosis of congestive heart failure	Diagnostic test: Thoracic bioimpedance tomography; Data collection using a thoracic bioimpedance tomography device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung congestion	Assessed using lung ultrasound over 12 thoracic zones to calculate the B-line score	Baseline, week 4, week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thoracic water content	Derived using high resolution CT-scan images	Baseline
Symptom burden	Assessed using the KCCQ-12 questionnaire	Baseline, week 4 and week 8
NT-pro-BNP	Measurement of NT-pro-BNP	Baseline, week 4, week 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Episodes of decompensated heart failure	Urgent visit or hospitalisation for worsening of heart failure symptoms requiering diuretic treatment or dialysis	90 days

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: September 17, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): October 6, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: heart failure; fluid management; bioimpedance; diuretic treatment
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 2025-12000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No